David T. Vroman, MD Assistant Professor of Ophthalmology

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Presentation transcript:

Quality of Life Analysis on Near Vision Following Implantation of an AcrySof ® ReSTOR ® IOL David T. Vroman, MD Assistant Professor of Ophthalmology Cornea, Cataract and Refractive Surgery Storm Eye Institute Medical University of South Carolina

AcrySof® ReSTOR® Apodized Diffractive IOL Design Incorporates the benefits of the AcrySof® IOL biomaterial Integrates advanced apodized diffractive design fundamentals Design intended to provide... Quality near, intermediate, and distance vision Increased spectacle freedom

Current Clinical Research Preliminary study compared new IOL with main market rival with excellent results US and European multi-center data used for approval Similar larger study in USA for FDA approval – includes comparison with AcrySof® Monofocal Control Non-Masked, Parallel Group, Non-Randomized Multi-Center Study Bilateral Implantation of ReSTOR® or Control

AcrySof ® ReSTOR ® Apodized Diffractive IOL Analysis of near vision utilizing the AcrySof® ReSTOR® IOL Quality of life data was analyzed using the modified Cataract TyPE specification instrument subjective questionnaire which measured limitations in near vision Acuity results include an evaluation of near VA under photopic and mesopic conditions Reading speed testing, performed in an independent study, demonstrate near visual acuity as an example of a near vision related activity

Near Photopic Visual Acuity Both Eyes, 6 Month Postoperative 20/15 20/20 20/25 20/30 20/40 20/50 20/60 Mean LogMAR, VA Best Distance, Uncorrected Best Distance, Distance Corrected Standard Distance, Best Corrected

Near Photopic Visual Acuity 1st Eye, 6 Month Postoperative Best Distance, Uncorrected Best Distance, Distance Corrected Standard Distance, Best Corrected 20/15 20/20 20/25 20/30 Mean LogMAR, VA 20/40 20/50 20/60

Near Mesopic VA 6 Months Postoperative Distance Corrected at Best Distance 20/15 First Eye Both Eyes 20/20 20/25 20/32 20/40 Mean LogMAR, VA 20/50 20/60 20/70

Limitations in Near Vision Without Glasses, Bilateral (6 month Post-op) Extreme limitation P < 0.0001 Limitation Score No limitation Treatment Group

Spectacle Freedom: Near Vision, 6 Months Postoperative Percentage of Subjects

Methods – Reading Speed Patients with bilateral Array (n=7), AcrySof ® monofocal (n=6), ReSTOR® (n=5) Video of patients reading a standardized paragraph at distance of their choice Best distance and time to read each line recorded

20/80 Equivalency Total Elapsed Time Array® Monofocal ReSTOR®

20/50 Equivalency Total Elapsed Time Array ® Monofocal ReSTOR ®

20/40 Equivalency Total Elapsed Time Array ® Monofocal ReSTOR ®

20/32 Equivalency Total Elapsed Time Array ® Monofocal ReSTOR ®

20/25 Equivalency Total Elapsed Time Array ® Monofocal ReSTOR ®

20/20 Equivalency Total Elapsed Time Array ® Monofocal ReSTOR ®

20/16 Equivalency Total Elapsed Time Array ® Monofocal ReSTOR ®

20/13 Equivalency Total Elapsed Time Array ® Monofocal ReSTOR ®

Last Legible LogMAR VA Equivalent Font Size Reading Speed Data Last Legible LogMAR VA Equivalent Font Size

AcrySof ® ReSTOR ® Apodized Diffractive IOL Conclusions AcrySof® ReSTOR® Apodized Diffractive IOL has received FDA approval Interim clinical results demonstrate functional near vision under various lighting conditions Enhances the quality of life for near vision related activities Subjects are able to maintain a constant pace of reading speed at variable distances

Thank You . ASCRS 2005